CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study
Redefining Optimal TAVR Outcomes
In a population in which two thirds of medically managed patients die by 2 years,1 63.5% of CoreValve extreme risk patients survive.
Low and Stable Stroke Rate
In addition to a low 1-year rate, only 0.9% of patients suffered a major stroke between 1 and 2 years.
Strong and Consistent Hemodynamic Performance
Supra-annular valve design optimizes orifice area, delivering low single-digit gradients out to two years.
Maintained Improvement in PVL
The CoreValve Nitinol frame conforms and seals to the annulus, maintaining PVL improvements seen at one year.
Stable Gains in Patient Functional Status
In a paired analysis, 92% of patients improved at least one class by two years, with 58% improving at least two classes.
Low Rate of Major Vascular Complications2
The CoreValve device has a low rate of major vascular complications in patients with vasculature down to 6mm, largely due to its low 18Fr delivery profile.
*Judged by a heart team, including a cardiac surgeon, these patients have a predicted risk of operative mortality and/or serious irreversible morbidity ≥50% at 30 days.
Data Presented at TCT 2014:
Yakubov SJ, et al. Long-term Outcomes Using a Self-Expanding Bioprosthesis in Patients with Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-year Results from the CoreValve US Pivotal Trial. Presented at TCT September 2014. Washington D.C.
- Leon MB, et al. Transcatheter aortic valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-1607.
- Popma JJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery, JACC 2014, doi: 10.1016/j.jacc.2014.02.556.